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news.Theralase Technologies has completed manufacture of a second batch of its lead Photo Dynamic Compound (PDC), TLD-1433 in compliance with Good Manufacturing Practice (GMP) standards.
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This milestone demonstrates Theralase’s ability to consistently and reliably manufacture its lead light activated drug in the same purity and yield as the original GMP batch.
Consistency in manufacture of TLD-1433 is essential to prove to regulatory agencies that a drug intended for the treatment of Non-Muscle Invasive Bladder Cancer ("NMIBC") can be reliably produced to GMP quality standards.
Theralase plans to evaluate TLD-1433 in a Phase Ib clinical trial aimed at proving the primary objective of safety and tolerability with an exploratory objective of efficacy commencing in late 4Q2015.
Theralase has completed and submitted all required documentation in 3Q2015 to Health Canada and University Health Network to evaluate the light activated drug for the lead indication of NMIBC.
Theralase president and CEO Roger Dumoulin-White said: "Theralase continues to execute on its strategic initiative to advance its anti-cancer technology to commence destroying NMIBC this year. Theralase has now demonstrated control of its manufacturing process to produce high grade TLD-1433 in large quantities.
"Pending successful completion of a Phase Ib and Phase II clinical study in NMIBC, Theralase now possesses the ability to rapidly ramp-up production of TLD-1433 in commercial quantities to supply oncology institutions, who treat this deadly disease."